ModifiedHealth NetPolicy N/A

Capmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Defines medical necessity and prior authorization criteria for capmatinib (Tabrecta) for adults with metastatic or recurrent non-small cell lung cancer (NSCLC) whose tumors harbor MET exon 14 skipping, and applies to Health Net lines of business described.

Policy Summary

PayerHealth Net

PolicyCapmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Policy CodePolicy N/A

Change TypeCriteria revisednon-coverage clarified

Effective DateSep 1, 2020

Next Review DateAug 25, 2025

Key ActionSubmit prior authorization with documentation of MET exon 14 skipping (FDA-approved test), oncologist involvement, age ≥18, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Added explicit non-coverage for positive MET amplification WITHOUT an Exon 14 skipping mutation.

Updated initial criteria to allow use as a single-agent for brain metastases per NCCN.

Clarified EGFR-mutant with high-level MET amplifications: Tabrecta can be administered with continuation of Tagrisso.

Added standard generic redirection language to require use of generic capmatinib when available.

800 mg/dayMaximum daily dose

400 mg BIDDosing regimen

150 mg, 200 mgTablet strengths

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Coverage Criteria for Capmatinib (Tabrecta)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy for Capmatinib: 1) Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); 2) Tumor is positive for a mutation causing MET exon 14 skipping (see Appendix D) detected by an FDA-approved test; 3) Prescribed by or in consultation with an oncologist; 4) Age >= 18 years; 5) Request meets ONE of the following: (a) disease is EGFR wild-type and ALK negative; (b) used as a single-agent for brain metastases; or (c) if EGFR mutant with high-level MET amplifications, Tabrecta can be administered with continuation of Tagrisso; 6) Dose does not exceed both of the following: (i) 800 mg per day and (ii) 4 tablets per day; if dosing exceeds these limits, the dose must be supported by practice guidelines or peer-reviewed literature and prescriber must submit supporting evidence; 7) Member must use generic capmatinib if available unless contraindicated or clinically significant adverse effects are experienced.

Prescribed regimen must be FDA‑approved or recommended by NCCN; prescriber must submit supporting evidence for off‑label dosing or uses.

Continuation — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met

Continued Therapy: 1) Member is currently receiving capmatinib via the Centene benefit or documentation supports current receipt of capmatinib for a covered indication for at least 30 days; 2) Diagnosis is non-small cell lung cancer (NSCLC); 3) Member is responding positively to therapy; 4) New dose does not exceed both of the following: (i) 800 mg per day and (ii) 4 tablets per day; if the request is for a dose increase, the increase must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence; 5) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less.

Coverage is NOT authorized for tumors that are positive for MET amplification WITHOUT an Exon 14 skipping mutation. Requests for capmatinib (Tabrecta) will be denied when the tumor harbors MET amplification only and no MET exon 14 skipping mutation, as this genotype is considered non-responsive and is specifically listed among indications for which coverage is not authorized.

Indications that are not FDA-approved and are not specifically addressed by this clinical policy are excluded from coverage unless the prescriber provides sufficient documentation of efficacy and safety in accordance with the applicable off-label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage provisions.

Coverage decisions and the administration of benefits for capmatinib are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance). State and federal requirements and applicable Health Plan administrative policies and procedures also apply.

Use of capmatinib for tumors with MET amplification only (without MET exon 14 skipping) is considered not medically necessary based on lack of evidence of efficacy; such tumors should not be approved for treatment with capmatinib per the policy's interpretation guidance.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for capmatinib (Tabrecta). Providers must submit documentation of diagnosis, mutation testing (including report interpretation showing MET exon 14 skipping), prior therapies, and other clinical information to support that the member meets all approval criteria.

Requests governed by this clinical policy and Health Plan administrative procedures.
Prescriptions should be by or in consultation with an oncologist and for members aged ≥18 years, when criteria are met.

Denial Risk

MET Amplification without Exon 14 Skipping — Not Covered

Requests for capmatinib will be denied when tumor testing shows MET amplification WITHOUT an Exon 14 skipping mutation. Presence of MET amplification alone, without exon 14 skipping, is considered not medically necessary for approval.

See Appendix D: pathology interpretation must state presence or absence of mutation causing MET exon 14 skipping.

Biomarker and Testing Requirements

MET exon 14 skipping — biomarker requirement entry

BiomarkerMutation that leads to MET exon 14 skipping detected by an FDA-approved test

Required for coveragePresence of a MET exon 14 skipping mutation is required for capmatinib (Tabrecta) coverage for metastatic NSCLC

Source wordingTabrecta is indicated for adult patients with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test

MET amplification — biomarker definition/coverage implication

DefinitionMET amplification refers to increased copy number of the MET gene as reported on the pathology/genomic test

Coverage implicationPositive MET amplification WITHOUT an Exon 14 skipping mutation is explicitly not authorized for coverage

Line of Therapy

first-line

Line of Therapy: Indicated for metastatic/recurrent NSCLC with MET exon 14 skipping; policy allows use for brain metastases and permits administration with continuation of Tagrisso in EGFR‑mutant disease with high‑level MET amplification as specified by NCCN guidance.

Dosing and Available Formulations

Regimen	Formulation / Strength	Coverage Status
400 mg PO twice daily (maximum 800 mg/day)	Tablets available: 150 mg and 200 mg	Covered with criteria

Definitions

Mutation causing MET exon 14 skipping — definition

TermMutation causing MET exon 14 skipping

DescriptionA genomic alteration in the MET gene that leads to skipping of exon 14 on mRNA and is interpreted by the pathologist who signs the report

Relevance to therapyThis specific mutation is the required biomarker for capmatinib indication in metastatic NSCLC

MET amplification (without exon 14 skipping) — definition and coverage implication

TermMET amplification (without exon 14 skipping)

DefinitionPresence of MET gene amplification in the absence of an MET exon 14 skipping mutation as reported on the test

Background

Capmatinib (Tabrecta) is an oral small-molecule kinase inhibitor that targets the MET receptor. It is indicated for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 skipping mutation detected by an FDA‑approved test. The recommended dosing for NSCLC is 400 mg orally twice daily (maximum 800 mg/day); tablets are available in 150 mg and 200 mg strengths. Clinical data and guideline recommendations note activity against central nervous system metastases in this population.